Walking Football as a Supportive Medicine for Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Is the Walking Football a Feasible Approach to Improve Health-related Quality of Life in Men With Prostate Cancer Receiving Androgen Deprivation Therapy? the PROSTATA_MOVE Randomized Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04062162
• Other study ID #: AICSO
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 11, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2020
• Source: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Androgen deprivation therapy (ADT) is widely used in men with prostate cancer (PCa) to delay disease progression and enhance survival. The use of ADT is often associated with a vast spectrum of side effects that considerably reduce quality of life. Exercise has been proposed as a non-pharmacological strategy to counter some adverse effects of ADT among patients with PCa. Particularly, recreational football-based interventions have been suggested as an enjoyment approach to involve patients with PCa in regular exercise practice. Given its intermittent nature and vigorous efforts, adverse events associated with recreational football practice have been reported. To handle this issue and to involve patients with PCa in recreational football practice, walking football has emerged as a more suitable exercise modality

Description:

This study was design as a randomized controlled trial, with two study arms, which aims to analyse the feasibility, safety of a supervised walking football program in patients with PCa. Moreover, the effects on health-related quality of life; bone mineral density; body composition; physical fitness; physical activity levels; inflammatory and metabolic profile; cognitive function; and cost-effectiveness will be complementarily analysed.

Recruitment will be conducted by invitation of Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E; Vila Nova de Gaia, Portugal, E.P.E) oncologists and urologists. Patients who agree to participate in this study will be referred to a study coordinator (medical oncologist) and will be randomly allocated (1:1 ratio) to one of the two study-arms.

In addition to standard PCa care, patients in the interventional group (IG) will perform 3 times per week a supervised Walking Football Program over 16 weeks and plus 16 additional weeks.

Patients allocated to control group (CG) will receive standard PCa medical care and will be instructed to maintain daily-life routines. After the first 16 weeks, the control group patients' will be invited to join and preform the exercise intervention (additional 16 weeks).

Walking football exercise sessions will be conducted on an indoor sports hall, supervised by one exercise physiologist and a football coach. Exercise intensity will be monitored through heart rate and rated perceived exertion.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with PCa

• Under castration therapy for more than 3 months

• Planned to be under castration for more than 6 months

• Follow-up at the Medical Oncology department and/or Urology department of the Hospital Center Vila Nova de Gaia/Espinho.

Exclusion Criteria:

• Medical or surgical contraindications for exercise.

• T-score < -2.5

Related Conditions & MeSH terms

• Androgen Deprivation Therapy
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Walking football training
Intervention will involve 3 sessions per week of a structured and supervised walking football program over 16 weeks. Each session will include a warm-up, followed by the practice of specific exercises where specific technical skills (pass, dribble, shot), motor skills (agility, coordination, balance) and physical fitness (cardiorespiratory and musculoskeletal capacity) will be enhanced, ending with a structured game (7x7) of walking football and a cooldown.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Vila Nova de Gaia / Espinho	Vila Nova de Gaia

Sponsors (6)

Lead Sponsor	Collaborator
Associacao de Investigacao de Cuidados de Suporte em Oncologia	Câmara Municipal de Gaia, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., Federação Portuguesa de Futebol, University Institute of Maia, University of Beira Interior

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate.	Assessed by the number of enrolled patients divided by the number of invited patients.	Baseline
Primary	Withdrawal rate	Assessed by the number of withdrawal patients	Change from baseline to 32 weeks
Primary	Appropriateness of outcomes assessments.	Assessed by the percentage of completed data.	Change from baseline to 32 weeks
Primary	Adherence to intervention.	Assessed by the number of completed sessions and the number of missed sessions.	Change from baseline to 32 weeks
Primary	Rate of Enjoyment	Assessed by the self-reported exercise sessions' enjoyment using a likert scale (1 [lowest] to 5 [highest] points).	Change from baseline to 32 weeks
Primary	Health-related quality of life	Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.	Change from baseline to 32 weeks
Secondary	Bone Mineral Density	Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.	Change from baseline to 32 weeks
Secondary	Body composition	Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.	Change from baseline to 32 weeks
Secondary	Aerobic capacity	Assessed by a symptom-limited exercise test on a treadmill	Change from baseline to 32 weeks
Secondary	Maximal isometric handgrip strength	Assessed using a digital handgrip dynamometer.	Change from baseline to 32 weeks
Secondary	Maximal isometric lower limb strength	Assessed using a digital handgrip dynamometer.	Change from baseline to 32 weeks
Secondary	Lower limb functionality	Assessed by the 30-seconds sit-to-stand test	Change from baseline to 32 weeks
Secondary	Static balance	Assessed by the single leg stance test	Change from baseline to 32 weeks
Secondary	Habitual physical activity levels	Assessed using accelerometers	Change from baseline to 32 weeks
Secondary	Exercise intensity - External load	Distance (km) assessed using GPS tracking during exercise	Change from baseline to 32 weeks
Secondary	Exercise intensity - Internal load	Assessed by the heart rate	Change from baseline to 32 weeks
Secondary	Exercise intensity - Rating of perceived exertion	Assessed using a 6-20 borg scale (minimum effort = 6; maximum effort = 10).	Change from baseline to 32 weeks
Secondary	Cogntive function	Assessed by the Montreal Cognitive Assessment	Change from baseline to 32 weeks
Secondary	Blood pressure	Assessed using a digital sphygmomanometer	Change from baseline to 32 weeks
Secondary	Resting heart rate	Assessed using a digital sphygmomanometer	Change from baseline to 32 weeks
Secondary	LDL-cholesterol	Blood sample will be taken for analysis of levels of LDL-cholesterol	Change from baseline to 32 weeks
Secondary	HDL-cholesterol	Blood sample will be taken for analysis of levels of HDL-cholesterol	Change from baseline to 32 weeks
Secondary	Total cholesterol	Blood sample will be taken for analysis of levels of total cholesterol	Change from baseline to 32 weeks
Secondary	Triglycerides	Blood sample will be taken for analysis of levels of triglycerides	Change from baseline to 32 weeks
Secondary	Prostate specific antigen (PSA)	Blood sample will be taken for analysis of levels of PSA	Change from baseline to 32 weeks
Secondary	Creatinine	Blood sample will be taken for analysis of levels of creatinine	Change from baseline to 32 weeks
Secondary	High sensitivity C-reactive protein (HS-CRP)	Blood sample will be taken for analysis of levels of HS-CRP	Change from baseline to 32 weeks
Secondary	N-terminal type B natriuretic peptide (NT-proBNP)	Blood sample will be taken for analysis of levels of NT-proBNP	Change from baseline to 32 weeks
Secondary	Vitamin D	Blood sample will be taken for analysis of levels of vitamin D	Change from baseline to 32 weeks
Secondary	Osteocalcin	Blood sample will be taken for analysis of levels of	Change from baseline to 32 weeks
Secondary	C-Telopeptide of Collagen Cross-links (CTx)	Blood sample will be taken for analysis of levels of CTx	Change from baseline to 32 weeks
Secondary	Bone Specific Alkaline Phosphatase (BSAP)	Blood sample will be taken for analysis of levels of BSAP	Change from baseline to 32 weeks
Secondary	Tartrate-Resistant Acid Phosphatase (TRAP)	Blood sample will be taken for analysis of levels of TRAP	Change from baseline to 32 weeks
Secondary	Glycated hemoglobin	Blood sample will be taken for analysis of levels of glycated hemoglobin	Change from baseline to 32 weeks
Secondary	Testosterone	Blood sample will be taken for analysis of levels of testosterone	Change from baseline to 32 weeks